Vitamins A And D Without Lanolin
FDA Label NDC 68786-411

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Vitamins A And D Without Lanolin (NDC 68786-411). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each gram), purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Gram)

White Petrolatum, USP, 93% w/w

Purpose

Skin Protectant

Uses


  • Temporarily protects minor
  • Cuts
  • Scrapes
  • Burns

  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from drying effects of wind and cold weather
  • Temporarily protects and helps relieve minor skin irritation and itching due to:
  • Rashes
  • Eczema

Warnings

For External Use Only.

When Using This Product

Do not get into eyes

Stop Use And Ask A Doctor If


  • The condition persists or gets worse
  • Symptoms last more than 7 days or clear up and occur again in a few days

Do Not Use On


  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Keep Out Of Reach Of Children


  • If swallowed, get medical help or contact a Poison Control Center right away

Directions


  • Apply as needed

Other Information


  • Store at controlled room temperature 15-30 C (59-86 F)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

Inactive Ingredients


  • Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

NDC 68786-411-01

Made In Israel

144 Packets

SionBiotext Medical Ltd.

For Professional and Hospital Use

Vitamin A and D

Ointment

without Lanolin

Ref.: 54J811-5201-000

Net Wt 5 gram



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